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KENGREXAL Powder for concentrate solution (2020)

Active ingredients: Cangrelor

Product Name and Form

Kengrexal 50 mg powder for concentrate for solution for injection/infusion.

Pharmaceutical form

Powder for concentrate for solution for injection/infusion.

White to off-white lyophilised powder.

Qualitative and Quantitative Composition

Each vial contains cangrelor tetrasodium corresponding to 50 mg cangrelor. After reconstitution 1 mL of concentrate contains 10 mg cangrelor. After dilution 1 mL of solution contains 200 micrograms cangrelor.

Excipient with known effect: Each vial contains 52.2 mg sorbitol.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Cangrelor

Cangrelor is a direct P2Y12 platelet receptor antagonist that blocks adenosine diphosphate (ADP)-induced platelet activation and aggregation in vitro and ex vivo. Cangrelor binds selectively and reversibly to the P2Y12 receptor to prevent further signalling and platelet activation.

List of excipients

Mannitol
Sorbitol
Sodium hydroxide (for pH-adjustment)

Pack sizes and Marketing

Powder in 10 mL glass vials (Type 1) closed with a Flurotec coated butyl rubber stopper and sealed with crimped aluminium seal.

Kengrexal is available in packs of 10 vials.

Marketing authorization holder
Authorization dates

Chiesi Farmaceutici S.p.A., Via Palermo, 26/A, 43122, Parma, Italy

Date of first authorisation: 23 March 2015

Marketing authorization number:

EU/1/15/994/001